MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95004
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set, stay safe/luer lock catheter extension, and the serious adverse events of peritonitis, which required hospitalization.The definitive etiology of the serious adverse events is unknown; therefore, causality could not firmly be established.However, the pdrn stated the peritonitis was likely caused by the separation of the liberty cycler set from the stay safe/luer lock catheter extension likely due to tugging.Esrd patients undergoing pd therapy (manual or cycler based) for rrt are at high risk for infections of the peritoneum.It should be noted that the lack of clinical follow-up precluded a more comprehensive investigation.Based on the information available, the liberty cycler set and stay safe/luer lock catheter extension cannot be disassociated from playing a possible causal or contributory role in the serious adverse events.There is currently no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction occurred.However, given the unknown definitive cause, missing clinical summary of events, discharge summary, and no manufacturer evaluation of the fresenius products in question; this clinical investigation cannot exclude the patient¿s liberty cycler set and stay safe/luer lock catheter extension from the serious adverse events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A peritoneal dialysis (pd) patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty cycler set and stay safe/luer lock catheter extension for renal replacement therapy (rrt) since on (b)(6) 2025 reported being hospitalized (date not provided) and diagnosed with peritonitis.During follow-up, the patient¿s pd registered nurse (pdrn) reported the patient experienced a disconnection (including fluid leak) between the liberty cycler set (patient line) and the stay safe/luer lock catheter extension on (b)(6) 2026.The pdrn reported the likely cause of the separation was due to ¿tugging,¿ however the definitive cause is unknown.The pdrn reported the patient was hospitalized shortly after the disconnection and was diagnosed with peritonitis.As of on (b)(6) 2026 the patient remained hospitalized and no further information was available.Subsequent attempts to obtain additional clinical information (e.G., patient demographics, discharge summary, hospital records, organism, medication records, causality) were unsuccessful.
Additional Manufacturer Narrative
Correction: h.5.
Event or Problem Description
A peritoneal dialysis (pd) patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty cycler set and stay safe/luer lock catheter extension for renal replacement therapy (rrt) since (b)(6) 2025 reported being hospitalized (date not provided) and diagnosed with peritonitis.During follow-up, the patient¿s pd registered nurse (pdrn) reported the patient experienced a disconnection (including fluid leak) between the liberty cycler set (patient line) and the stay safe/luer lock catheter extension on (b)(6) 2026.The pdrn reported the likely cause of the separation was due to ¿tugging,¿ however the definitive cause is unknown.The pdrn reported the patient was hospitalized shortly after the disconnection and was diagnosed with peritonitis.As of (b)(6) 2026 the patient remained hospitalized and no further information was available.Subsequent attempts to obtain additional clinical information (e.G., patient demographics, discharge summary, hospital records, organism, medication records, causality) were unsuccessful.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Event or Problem Description
A peritoneal dialysis (pd) patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty cycler set and stay safe/luer lock catheter extension for renal replacement therapy (rrt) since (b)(6) 2025 reported being hospitalized (date not provided) and diagnosed with peritonitis.During follow-up, the patient¿s pd registered nurse (pdrn) reported the patient experienced a disconnection (including fluid leak) between the liberty cycler set (patient line) and the stay safe/luer lock catheter extension on (b)(6) 2026.The pdrn reported the likely cause of the separation was due to ¿tugging,¿ however the definitive cause is unknown.The pdrn reported the patient was hospitalized shortly after the disconnection and was diagnosed with peritonitis.As of (b)(6) 2026 the patient remained hospitalized and no further information was available.Subsequent attempts to obtain additional clinical information (e.G., patient demographics, discharge summary, hospital records, organism, medication records, causality) were unsuccessful.

• Brand Name: STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 24329219
• Report Number: 0008030665-2026-00304
• Device Sequence Number: 11981048
• Product Code: KDJ
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-95004
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 05/27/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 02/25/2026; 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 94 KG